Express Pharma

JULY 3, 2023

How is the industry’s approach to drug development transforming? How is Waters aiding advancements in drug development? A central aim in drug development is to create new molecular entities into commercially viable drugs useful in managing diseases. What are the imperatives that led to this change?

Biosimilars 78

Biosimilars Drug Development Generic Medicine Diabetes 78

European Pharmaceutical Review

FEBRUARY 27, 2024

Amgen drug development highlights – November 2023 In November 2023, Phase II trial results for immunotherapy tarlatamab demonstrated an ability to provide sustained anti-tumour activity in 40 percent of the small cell lung cancer trial patients.

Biosimilars 105

Biosimilars Pharmaceutical Companies Pharmaceutical Companies Drug Development 105

Express Pharma

JUNE 5, 2023

Jakafi’s landmark approval in 2011 galvanised intensive drug development efforts by providing a strong positive investment signal for this market, as Jakafi is a blockbuster agent. Sam Warburton, Oncology Analyst at GlobalData, comments, “Despite MF being a rare disease, it is a blockbuster market with significant commercial potential.

Drug Development 84

Drug Development Biosimilars Compounding 84

Pharmaceutical Technology

MAY 23, 2023

This change significantly diminishes the protection afforded by market exclusivity by allowing off-patent competitors to submit marketing authorisation applications for generic or biosimilar products with less than two years of exclusivity remaining. The standard period of orphan market exclusivity is set to be reduced from ten to nine years.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Biosimilars Packaging 52

Express Pharma

JULY 10, 2024

With advancements in biotechnology, robust scientific capabilities, cost-effective manufacturing processes, a large workforce and a shift towards more complex biologic drugs, India is at the cusp of a huge opportunity to emerge as a leader in biopharma. On a monthly basis, this market adds around $1.16 billion.”

Vaccines 80

Vaccines Drug Development Process Improvement Biosimilars 80

FDA Law Blog: Biosimilars

JULY 9, 2024

Another question is the impact on rare disease drug development, where broader populations are small and there may be limited knowledge about differential impacts of disease. If FDA meets this timeline, the requirement to submit DAPs for relevant clinical studies would begin around the end of 2025.

Drug Development 57

Drug Development Communication Documentation Labelling 57